MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a nonreactive (negative) atellica im hepatitis b surface antigen ii (hbsii) result which was discordant relative to clinical expectation and repeat testing when using lot# 318.An initial nonreactive (negative) result was obtained for the patient sample in question.The nonreactive result was reported to the physician(s), who questioned the result.A new sample was drawn from the same patient and tested on an alternate analyzer which produced a reactive (positive) result.Per the assay¿s instructions for use (ifu), the initial reactive patient samples should be repeated in duplicate, the best 2 of 3 should be considered the patients¿ initial result and to be confirmed with the atellica im hbsag confirmatory assay, additional hbv marker assays, or another approved confirmatory method if warranted or necessary.The customer followed the ifu and repeated the sample in duplicate.Consensus result = reactive.Later, confirmatory testing was performed on the original and alternate analyzers which also produced reactive results.The same sample was then sent out to an alternate facility and tested using an alternate methodology which also produced a reactive result.The reactive results were considered correct, and a corrected report was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer reported observation of a nonreactive (negative) atellica im hepatitis b surface antigen ii (hbsii) result which was discordant relative to clinical expectation and repeat testing.Siemens evaluated the instrument data and the information provided by the customer.No reagent anomalies were identified; quality control (qc) met acceptance criteria, and calibration was valid at the time of testing.Additionally, no other patient samples were observed to be affected.The assay¿s instructions for use (ifu) states the following, under interpretation of results: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ return of the patient sample for further investigation was not warranted, as the customer performed testing in accordance with the assay instructions for use (ifu).Additional testing utilizing hbt/nabt scantibodies tubes could not be completed due to insufficient sample volume.Based on the available information, the cause of the discordant result was sample-specific interference.A product problem was not identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24914443
• Report Number: 1219913-2026-00081
• Device Sequence Number: 18610577
• Product Code: LOM
• UDI-Device Identifier: 00630414599274
• UDI-Public: (01)00630414599274(10)17908318(17)260905
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110041-S004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995604
• Device Lot Number: 17908318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female